Code Standards

3 Making Statements: Claims, Quotes & References

Making Statements: Claims, Quotes & References

3.1

Claims and/or quotations in Advertising/Promotion Systems must be consistent with, and within the limitations of, the Health Canada TMA. Any APS containing direct or indirect product claims and/or quotes from scientific literature must include a complete listing of the scientific references. Labelling must be authorized by Health Canada. See Making Comparisons, Section 5, for claims that are of a comparative nature.

Consistency

Making Statements: Claims, Quotes & References

Relevancy A

Relevancy B

3.1.1

Clinicalor therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.

Making Statements: Claims, Quotes & References

Consistency

Relevancy A

3.1.2

Unpublished data is regarded as having received independent review when:

i) There is evidence that an editor of a peer-reviewed journal has accepted this data (or study) for future publication.

or

ii) The data has been reviewed as part of a submission to Health Canada and there is evidence of acceptance indicated by inclusion in the TMA. Citation in the bibliography section of the TMA does not indicate proof of acceptance by Health Canada.

Please note that abstracts presented at conferences and/or in journal supplements (such as study design and results analyses) that have not been subject to independent review are generally regarded as not having sufficient evidence to support claims and may not be used as reference in APS.

Papers published in journal supplements must demonstrate that the supplement has also been subject to a rigorous peer-review process similar to the attached journal.

Making Statements: Claims, Quotes & References

Relevancy A

3.1.3

Non-evidence based statements such as testimonials regarding adverse drug reactions are not acceptable. Testimonial statements consistent with data and supported by evidence may be used.

Making Statements: Claims, Quotes & References

Relevancy A

3.1.4

Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance, unless there is evidence of a valid clinical correlation.

Making Statements: Claims, Quotes & References

Relevancy B

3.1.5

Claims or quotations that are out of context or inconsistent with the conclusions of the cited author(s) will not be accepted.

Making Statements: Claims, Quotes & References

Relevancy B

3.1.6

Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote, (for example, an indication or dosage that is limited or that is restricted to a specific group of patients must not form part of a footnote and must be contained in the body copy).

Making Statements: Claims, Quotes & References

Relevancy B

3.1.7

With respect to advertising of non-prescription drugs without a Product Monograph, a Senior Regulatory Official of the Market Authorization Holder (MAH) may provide confirmation that a claim has been approved by Health Canada, for example: “Name of the Market Authorization Holder hereby attests that the claim (specific expanded claim) has been authorized by Health Canada for (complete product Brand name).” The MAH may be asked to provide further information.

Making Statements: Claims, Quotes & References

Relevancy A

3.1.8

For Drug Identification Number (DIN) products transitioned to Natural Product Numbers (NPNs), the Product License is the preferred evidentiary support for claims. However, the previously accepted Product Monograph will be considered acceptable evidence to support claims made regarding the transitioned Natural Health Product (NHP). This does not apply to products whose ingredients were altered. The previously accepted Product Monograph may not be used to support claims that are inconsistent with the current TMA.

Making Statements: Claims, Quotes & References

Relevancy A

3.1.9

PAAB may allow the use of sub-group analysis with specific conditions.

Making Statements: Claims, Quotes & References

Relevancy A

3.1.10

Secondary endpoints should be clearly identified as such and the primary endpoint of the study should be presented in close proximity when warranted.

Making Statements: Claims, Quotes & References

Relevancy B

3.1.11

PAAB may allow the use of observational studies when specific acceptance criteria are met.

Making Statements: Claims, Quotes & References

Relevancy A

3.2

All reference materials, both published and unpublished should be the most recent available, consistent with current Canadian medical opinion and practice and be within the limitations of the Health Canada accepted TMA. Canadian guidelines are to be adhered to and only in the event that they are not available see the following for guidance on international guidelines. What Constitutes Current Medical Opinion.

Consistency

Making Statements: Claims, Quotes & References

3.2.1

Current literature may be used to supplement information contained in the TMA or provide further verification of relevant information in the TMA.

Making Statements: Claims, Quotes & References

Consistency

3.2.2

Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

Making Statements: Claims, Quotes & References

Consistency

3.2.3

Reference to research or ongoing studies may be made in a non-promotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, which has been completed, has undergone an interim analysis, or has been presented at a medical meeting, and incorporates information that is not included in the Health Canada TMA, must not be mentioned in advertising.

Making Statements: Claims, Quotes & References

3.3

References cited in the APS must be available to health professionals on request, in English and/or French, either in their original form or translated.

Data on file must be made available to the Commissioner and may be classified as ‘Confidential’ by the advertiser or the author (pending publication).

A copy of the summary of the Data on File must be provided to health professionals upon request.

Making Statements: Claims, Quotes & References

Relevancy A

Transparency F

3.4

Copies of all reference sources cited in an APS must be provided to the PAAB Commissioner for verification of claims and/or quotes.

Making Statements: Claims, Quotes & References

Relevancy A

Transparency F

3.5

APS containing claims or quotes that emphasize only positive features of a pharmaceutical product, while ignoring significant negative findings, are not acceptable.

Making Statements: Claims, Quotes & References

Relevancy B

Transparency A

Transparency B

3.5.1

The body copy must contain reference to any negative findings in a prominent manner.

Making Statements: Claims, Quotes & References

Transparency A

Transparency B

Relevancy B

3.6

Quotes excerpted from published or unpublished scientific literature must be verbatim as presented in the source, and in context. Any deletions should be identified by a series of dots. Deletions of negative findings or other significant information relative to the product and or its use(s) will not be acceptable.

Making Statements: Claims, Quotes & References

Relevancy B

3.7

Claims or selected quotations must not refer to other products or different formulations of the same active ingredients unless authoritative data are available to warrant cross-referencing between products. See Equivalence, Section 5.13.